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Court certifies Surrey woman’s class action against drug maker

Surrey resident says she was not warned of risks of taking antidepressant Paxil while pregnant

A bottle of anti-depressant pills named Paxil are shown March 23, 2004 photographed in Miami, Florida. The Food and Drug Administration asked makers of popular anti-depressants to add or strengthen suicide-related warnings on their labels as well as the possibility of worsening depression especially at the beginning of treatment or when the doses are increased or decreased.

Photograph by: Joe Raedle
, Getty Images

The case of a Surrey woman who alleges her use of the antidepressant Paxil during pregnancy resulted in her baby being born with a hole in her heart has been certified as a class-action lawsuit against one of the world’s largest drug companies.

Faith Gibson was first prescribed Paxil — manufactured by U.K. pharmaceutical firm GlaxoSmithKline — in 2002, and continued to take it through pregnancy. Her daughter, Meah Bartram, was born Sept. 14, 2005 with a hole between the ventricular chambers of her heart.

Information suggesting an association between the use of Paxil during pregnancy and cardiovascular defects in newborns was first published by the company two weeks after Bartram was born, but Gibson and the other plaintiffs allege GlaxoSmithKline knew or should have known the risk before then.

Gibson said in an affidavit that had she known the potential risk to her child from taking Paxil, she would have taken another antidepressant, or none at all.

B.C. Supreme Court Justice Nathan Smith certified the case as a class action on Monday, with Gibson representing “any person in Canada, born with cardiovascular defects, to women who ingested Paxil while pregnant, and the mothers of those persons.”

David Klein, one of the lawyers representing Gibson, said the lawyers have been contacted by about a dozen such women from across the country and estimated there could be a couple of hundred more who may be eligible. B.C. residents who meet the class criteria are automatically included in the action, but residents of other provinces must opt in, he said.

Paxil is approved for use in Canada to treat conditions such as depression, obsessive-compulsive disorder and post-traumatic stress disorder. The original description, provided by the company to doctors who prescribe the drug, noted that the safety of Paxil in human pregnancy had not been established and that the drug “should not be used during pregnancy unless the potential benefit to the patient outweighs the risk to the fetus.”

The company updated that description in September 2004 to report respiratory and other complications requiring hospitalization of newborns exposed to Paxil during the third trimester of pregnancy.

On Sept. 29, 2005, two weeks after Bartram was born, GlaxoSmithKline advised Health Canada, doctors and others of the results of a retroactive study of 3,581 women exposed to paroxetine (the active ingredient in Paxil) and other anti-depressants during the first trimester of pregnancy. The study found a two-fold increased risk of both congenital birth defects and cardiovascular defects in children born to women exposed to paroxetine as compared to other antidepressants.

“Prescribers should carefully evaluate this new information when considering the use of paroxetine in women who are pregnant or planning pregnancy. This information should be discussed with the patient,” the advisory said.

The lawsuit’s statement of claim alleges negligence on the part of GlaxoSmithKline, including failure to adequately test Paxil and conduct adequate followup studies, failure to provide complete and accurate information to Health Canada and failure to warn doctors and patients of the risk of cardiovascular complications. None of the allegations have been proven in court.

Central to the case will be “whether the information published by (GlaxoSmithKline) at any given time reflected all that it knew or ought to have known, and whether the warnings issued could and should have been issued at an earlier date,” Smith wrote in his judgment certifying the class action.

GlaxoSmithKline has not filed a statement of defence.

Klein said it is the only such class action he is aware of in North America. A similar suit in Saskatchewan did not proceed and American courts have awarded damages in individual actions involving the use of Paxil by pregnant women, he said.

Spotlights

A bottle of anti-depressant pills named Paxil are shown March 23, 2004 photographed in Miami, Florida. The Food and Drug Administration asked makers of popular anti-depressants to add or strengthen suicide-related warnings on their labels as well as the possibility of worsening depression especially at the beginning of treatment or when the doses are increased or decreased.